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Irinotecan hydrochloride composition and preparation method thereof

A technology for irinotecan hydrochloride and its composition, which is applied in the field of irinotecan hydrochloride composition and its preparation, can solve the problems of inaccurate composition content, difficult filtration, unstable quality, etc., and achieve accurate content, high content, and guaranteed The effect of quality and stability

Inactive Publication Date: 2012-12-19
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0017] In view of the deficiencies in the prior art, in order to overcome the solid precipitation of the irinotecan hydrochloride composition during the preparation process, solve the difficulty of filtration in the preparation process, the final composition content is not accurate, and the quality is unstable. Research, unexpectedly found that dissolving irinotecan hydrochloride in the pre-configured solution, no solid precipitation, the method is simple, no additional heating or adding solvents, the obtained composition is accurate in content and stable in quality

Method used

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  • Irinotecan hydrochloride composition and preparation method thereof
  • Irinotecan hydrochloride composition and preparation method thereof
  • Irinotecan hydrochloride composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047]

[0048]

[0049] Weigh sorbitol and lactic acid into a container, add 90% water for injection, adjust the pH to 3.0~4.0 with 1mol / L sodium hydroxide solution, add irinotecan hydrochloride, dissolve and add water for injection to the full amount, then add 0.1% The activated carbon was stirred for 20 minutes and then decarburized, filtered with a 0.22 μm microporous membrane until it was clear, and the intermediate was measured, filled in a vial, plugged with a butyl rubber stopper and capped; the sample was autoclaved and leaked, Light pick up, and deliver after passing the quality inspection to be packaged, promptly obtain irinotecan hydrochloride composition.

Embodiment 2

[0051]

[0052] Weigh sorbitol and lactic acid into a container, add 90% water for injection, adjust the pH to 3.0~4.0 with sodium phosphate buffer, add irinotecan hydrochloride, dissolve and add water for injection to the full amount, then add 0.1% activated carbon After stirring for 20 minutes, decarburize, filter with a 0.22 μm microporous membrane until clear, measure the intermediate, fill it in a vial, plug it with a butyl rubber stopper and cap it; , and send it to be packaged after passing the quality inspection to obtain the irinotecan hydrochloride composition.

Embodiment 3

[0054]

[0055] Weigh sorbitol and lactic acid into a container, add 90% water for injection, adjust the pH to 3.0~4.0 with 0.05mol / L sodium hydroxide solution, add irinotecan hydrochloride, dissolve and add water for injection to the full amount, then add 0.1 % activated carbon was stirred for 20 minutes, decarburized, filtered with a 0.22 μm microporous membrane until clear, tested for the intermediate, filled in a vial, plugged with a butyl rubber stopper and capped; the sample was autoclaved and leaked , pick it up, and send it to pack after passing the quality inspection to obtain the irinotecan hydrochloride composition.

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PUM

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Abstract

The invention relates to an irinotecan hydrochloride composition, which is a composition by using irinotecan hydrochloride as a main drug and an auxiliary solution consisting of sorbic alcohol, lactic acid, alkaline regulation solution and injection water as dissolving solution. The preparation method comprises the following steps: weighing sorbic alcohol and lactic acid in a container according to the prescription, adding the injection water, stirring to dissolve, and regulating the pH to be between 3.0 and 4.0 with the alkaline regulation solution; adding the irinotecan hydrochloride with the amount of the prescription, dissolving, adding 0.1 percent activated carbon, stirring for 20 minutes, and decarburizing; filtering with a 0.22mu m microporous filter membrane until the mixture is clear; detecting the intermediate substance; filling in a penicillin bottle, plugging a butyl rubber plug, and rolling a cap; and performing leakage inspection and light inspection to the sample after high-pressure sterilization, and packaging after the sample is qualified in quality inspection.

Description

technical field [0001] The invention relates to an irinotecan hydrochloride pharmaceutical preparation, specifically, the invention provides an irinotecan hydrochloride composition and a preparation method thereof. Background technique [0002] Irinotecan hydrochloride is a water-soluble camptothecin derivative jointly developed by Japan's Daiichi Seiyaku Company and YakultHonsha Company. The chemical name is (S)-4,11-diethyl-3,4,12,14-tetrahydro- 4-Hydroxy-3,14-dioxo-1H-pyrano[3',4':6,7]indeno[1,2-b]quinolin-9-yl 1,4'-bis Piperidine-1'-carboxylate hydrochloride trihydrate. [0003] Its structural formula is: [0004] [0005] Molecular formula: C 33 h 38 N 4 o 6 .HCl.3H 2 o [0006] Molecular weight: 677.18 [0007] Colorectal cancer is a common malignant tumor of the gastrointestinal tract, second only to gastric cancer and esophageal cancer. Specifically, it refers to the malignant lesions of the large intestine mucosal epithelium that occur under the action ...

Claims

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Application Information

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IPC IPC(8): A61K31/4745A61K9/08A61K47/12A61P35/00
Inventor 赵小伟刘留成杨奇珍
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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